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SLP Model Development in the Diagnosis of COPD Patients — SLPCOPD  

COPD Clinical Trial

Official title:
A Comparative, Multi Centre Study, to Develop a Model for Structured Light Plethysmography Against Standard of Care in the Diagnosis of Chronic Obstructive Pulmonary Disease for Patients Who Plan to Undergo Spirometry Testing

Clinical Trial Summary

This is an observational, comparative, multicentre study to develop a model for the Thora3Di™ against standard practice in patients who are undergoing investigation for COPD. The core methodology involves capturing of data during a short period of measurement of breathing using SLP against spirometric outcomes.

Clinical Trial Description

This study will generate data to characterise the tidal breathing patterns and parameters with Thora-3Di™ against spirometry FEV1/FVC and %predicted. Subjects will have a Part A visit (Development Phase) to develop algorithms for COPD diagnosis. At Part A visit, subjects will have two 5-minute SLP measurements (Pre and Post bronchodilator). The SLP measurement should be performed prior to standard lung function tests with minimal impact on clinical time and no change to hospital attendance. Also, subjects will be asked to report concomitant medications and adverse events and fill in COPD assessment test (CAT™). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04584801
Study type Observational
Source Pneumacare Ltd
Contact
Status Completed
Phase
Start date May 5, 2021
Completion date June 15, 2023
View Details
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